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Fulvestrant-Containing Therapy Not Superior to Anastrozole in ER-Rich/ERBB2− BC
Key clinical point: Neoadjuvant endocrine therapy with fulvestrant or anastrozole + fulvestrant led to an endocrine-sensitive disease rate (ESDR) comparable to anastrozole alone in postmenopausal women with estrogen receptor (ER)-rich, human epidermal growth factor receptor 2-negative (ERBB2−) breast cancer (BC).
Major finding: Both fulvestrant and anastrozole + fulvestrant vs anastrozole alone demonstrated no significant improvement in the ESDR at 6 months (22.8% and 20.5% vs 18.7%, respectively; Wald test, P ≥ .98) and median percentage change in Ki67 at 4 weeks (−79.1% and −83.5% vs −80.6%, respectively; P ≥ .15).
Study details: Findings are from the phase 3 ALTERNATE trial, which included 1298 treatment-naive postmenopausal women with ER-rich/ERBB2− BC who were randomly assigned to receive anastrozole, fulvestrant, or anastrozole + fulvestrant for 6 months in a neoadjuvant setting.
Disclosures: This study was supported by the US National Institutes of Health (NIH)/National Cancer Institute (NCI) and other sources. Several authors declared receiving grants, personal fees, or research support or having other ties with various sources, including NIH/NCI.
Source: Ma CX, Suman VJ, Sanati S, et al. Endocrine-sensitive disease rate in postmenopausal patients with estrogen receptor-rich/ERBB2-negative breast cancer receiving neoadjuvant anastrozole, fulvestrant, or their combination: A phase 3 randomized clinical trial. JAMA Oncol. 2024 (Jan 18). doi: 10.1001/jamaoncol.2023.6038 Source
Key clinical point: Neoadjuvant endocrine therapy with fulvestrant or anastrozole + fulvestrant led to an endocrine-sensitive disease rate (ESDR) comparable to anastrozole alone in postmenopausal women with estrogen receptor (ER)-rich, human epidermal growth factor receptor 2-negative (ERBB2−) breast cancer (BC).
Major finding: Both fulvestrant and anastrozole + fulvestrant vs anastrozole alone demonstrated no significant improvement in the ESDR at 6 months (22.8% and 20.5% vs 18.7%, respectively; Wald test, P ≥ .98) and median percentage change in Ki67 at 4 weeks (−79.1% and −83.5% vs −80.6%, respectively; P ≥ .15).
Study details: Findings are from the phase 3 ALTERNATE trial, which included 1298 treatment-naive postmenopausal women with ER-rich/ERBB2− BC who were randomly assigned to receive anastrozole, fulvestrant, or anastrozole + fulvestrant for 6 months in a neoadjuvant setting.
Disclosures: This study was supported by the US National Institutes of Health (NIH)/National Cancer Institute (NCI) and other sources. Several authors declared receiving grants, personal fees, or research support or having other ties with various sources, including NIH/NCI.
Source: Ma CX, Suman VJ, Sanati S, et al. Endocrine-sensitive disease rate in postmenopausal patients with estrogen receptor-rich/ERBB2-negative breast cancer receiving neoadjuvant anastrozole, fulvestrant, or their combination: A phase 3 randomized clinical trial. JAMA Oncol. 2024 (Jan 18). doi: 10.1001/jamaoncol.2023.6038 Source
Key clinical point: Neoadjuvant endocrine therapy with fulvestrant or anastrozole + fulvestrant led to an endocrine-sensitive disease rate (ESDR) comparable to anastrozole alone in postmenopausal women with estrogen receptor (ER)-rich, human epidermal growth factor receptor 2-negative (ERBB2−) breast cancer (BC).
Major finding: Both fulvestrant and anastrozole + fulvestrant vs anastrozole alone demonstrated no significant improvement in the ESDR at 6 months (22.8% and 20.5% vs 18.7%, respectively; Wald test, P ≥ .98) and median percentage change in Ki67 at 4 weeks (−79.1% and −83.5% vs −80.6%, respectively; P ≥ .15).
Study details: Findings are from the phase 3 ALTERNATE trial, which included 1298 treatment-naive postmenopausal women with ER-rich/ERBB2− BC who were randomly assigned to receive anastrozole, fulvestrant, or anastrozole + fulvestrant for 6 months in a neoadjuvant setting.
Disclosures: This study was supported by the US National Institutes of Health (NIH)/National Cancer Institute (NCI) and other sources. Several authors declared receiving grants, personal fees, or research support or having other ties with various sources, including NIH/NCI.
Source: Ma CX, Suman VJ, Sanati S, et al. Endocrine-sensitive disease rate in postmenopausal patients with estrogen receptor-rich/ERBB2-negative breast cancer receiving neoadjuvant anastrozole, fulvestrant, or their combination: A phase 3 randomized clinical trial. JAMA Oncol. 2024 (Jan 18). doi: 10.1001/jamaoncol.2023.6038 Source
Body Fat Tied to Skeletal Fragility in Postmenopausal Women with AI-Treated Breast Cancer
Key clinical point: High initial fat body mass was associated with a risk for vertebral fracture (VF) progression in postmenopausal women with hormone receptor-positive (HR+) early breast cancer (BC) who received aromatase inhibitors (AI) plus denosumab.
Major finding: After 18 months of adjuvant therapy with AI and denosumab, 4.4% of patients had VF progression, with percentage of fat body mass (odds ratio [OR] 5.41; P = .01) and Fracture Risk Assessment Tool score (OR 3.95; P = .04) being independently associated with VF progression risk.
Study details: Findings are from a prospective cohort study including 237 postmenopausal women with HR+ early BC who received adjuvant therapy with AI and denosumab.
Disclosures: This study did not declare any specific funding. Three authors declared receiving personal fees or grants or having other ties with various sources.
Source: Cosentini D, Pedersini R, Mauro PD, et al. Fat body mass and vertebral fracture progression in women with breast cancer. JAMA Netw Open. 2024;7:e2350950. doi:10.1001/jamanetworkopen.2023.50950 Source
Key clinical point: High initial fat body mass was associated with a risk for vertebral fracture (VF) progression in postmenopausal women with hormone receptor-positive (HR+) early breast cancer (BC) who received aromatase inhibitors (AI) plus denosumab.
Major finding: After 18 months of adjuvant therapy with AI and denosumab, 4.4% of patients had VF progression, with percentage of fat body mass (odds ratio [OR] 5.41; P = .01) and Fracture Risk Assessment Tool score (OR 3.95; P = .04) being independently associated with VF progression risk.
Study details: Findings are from a prospective cohort study including 237 postmenopausal women with HR+ early BC who received adjuvant therapy with AI and denosumab.
Disclosures: This study did not declare any specific funding. Three authors declared receiving personal fees or grants or having other ties with various sources.
Source: Cosentini D, Pedersini R, Mauro PD, et al. Fat body mass and vertebral fracture progression in women with breast cancer. JAMA Netw Open. 2024;7:e2350950. doi:10.1001/jamanetworkopen.2023.50950 Source
Key clinical point: High initial fat body mass was associated with a risk for vertebral fracture (VF) progression in postmenopausal women with hormone receptor-positive (HR+) early breast cancer (BC) who received aromatase inhibitors (AI) plus denosumab.
Major finding: After 18 months of adjuvant therapy with AI and denosumab, 4.4% of patients had VF progression, with percentage of fat body mass (odds ratio [OR] 5.41; P = .01) and Fracture Risk Assessment Tool score (OR 3.95; P = .04) being independently associated with VF progression risk.
Study details: Findings are from a prospective cohort study including 237 postmenopausal women with HR+ early BC who received adjuvant therapy with AI and denosumab.
Disclosures: This study did not declare any specific funding. Three authors declared receiving personal fees or grants or having other ties with various sources.
Source: Cosentini D, Pedersini R, Mauro PD, et al. Fat body mass and vertebral fracture progression in women with breast cancer. JAMA Netw Open. 2024;7:e2350950. doi:10.1001/jamanetworkopen.2023.50950 Source
AHA: Urgent Need To Reduce Maternal Postpartum CVD Risk
Complications during pregnancy may be a wake-up call pointing to a higher risk for cardiovascular (CVD) and other diseases later in life. Therefore, the postpartum and interpregnancy periods are opportune windows for reducing CVD susceptibility and providing preventive care, especially for mothers with a history of adverse pregnancy outcomes (APOs). To that end, the American Heart Association recently released a scientific statement in Circulation outlining pregnancy-related CVD risks and reviewing evidence for preventive lifestyle strategies based on the AHA’s Life’s Essential 8 recommendations.
The Life’s Essential 8 encompass healthy eating, sleeping, and activity patterns; controlling weight, blood pressure, cholesterol, and blood sugar; and avoiding tobacco use.
“The motivation behind this statement was that complications in pregnancy are becoming more common and we now have more understanding that these serve as important risk factors for heart disease later in life,” said Jennifer Lewey, MD, MPH, director of the Penn Women’s Cardiovascular Health Program and an assistant professor of medicine at the University of Pennsylvania Perelman School of Medicine in Philadelphia.
“These risk factors are underrecognized and underappreciated. Clinicians don’t feel comfortable counseling their patients about how to reduce their cardiovascular disease risk,” Dr. Lewey, chair of the AHA writing group, said in an interview.
“So we thought this was the perfect time to highlight what we know and don’t know about how to care for this population,” she said.
APOs predispose mothers to heart disease and other long-term complications, including heart failure, stroke, chronic kidney disease, and vascular dementia. “Pregnancy is a significant stress on the body, and APOs such as preeclampsia can lead to vascular changes in the blood vessels and structural changes to the heart that can persist long term,” Dr. Lewey explained. Reduced maternal physical activity and unshed weight can compound the problem.
Varying by race and ethnicity, the proportion of mothers experiencing pregnancy complications, such as high blood pressure, gestational diabetes, and/or preterm birth is estimated at 10%-20%, the statement authors noted. These complications may serve as a wake-up call to young mothers.
The AHA panel believes that identifying at-risk women at younger ages will enable prevention through lifestyle changes and timely treatment. Little is known, however about what specific care may best reduce long-term CVD risk in women who had pregnancy complications, Dr. Lewey said. While randomized clinical trials have yet to evaluate the effects of postpartum interventions on CVD outcomes, the need for strategies supported by rigorous evidence is clear. “In particular, the fourth trimester, defined as the 12 weeks after delivery, is an optimal time to engage postpartum individuals in care to reduce maternal morbidity and improve care transitions,” the AHA group wrote.
An earlier AHA statement in 2021 recommended frequent cardiac risk factor screening in the first year postpartum at 6 and 12 weeks and again at 6 and 12 months, with appropriate transition from postpartum to longitudinal primary care around the 8- to 12-week mark.
Among the current statement’s findings: High blood pressure is the most prevalent cardiovascular condition during pregnancy, and the last two decades have seen a 25% increase in preeclampsia.
Hypertension during pregnancy carries a two- to fourfold higher risk of chronic hypertension within 2-7 years.
Women with one or more APOs experience heart attack and stroke at younger ages. Commenting on the statement but not involved in it, internist Natalie A. Cameron, MD, a primary and preventive care physician at Northwestern Medicine in Chicago, said, “This statement will be very helpful for physicians from a primary care perspective, especially since in internal medicine we don’t standardly receive education in cardiovascular health in the context of pregnancy and the first year postpartum.”
Dr. Cameron also noted that new research suggests the mother’s cardiovascular health during pregnancy can affect the child’s health through adolescence. “There’s a potential intergenerational effect and there may even be some programming and changes to the offspring in utero related to maternal lifestyle factors.”
While the postpartum period would seem like an opportune time to piggyback postpartum visits with infant wellness checkups, “the fact is that, in the U.S., many mothers are lost to care after delivery,” Dr. Lewey said. “But it’s essential to ensure transition to postpartum care.”
According to Dr. Cameron, physicians should be aware of the risk factor data and educate their pregnant and postpartum patients about reducing risk factors. “As I like to say, ‘If you’re going to take care of others, you need to take care of yourself first.’ ” While this statement may be a good starting point, future trials are needed to improve screening for subclinical CVD in individuals with APOs before symptom onset, the statement authors wrote.
This scientific statement was prepared on behalf of the American Heart Association. Dr. Lewey and several coauthors reported research funding from various agencies within the National Institutes of Health. Dr. Brown reported research funding from a cy-près court settlement with Wyeth. Dr. Cameron had no competing interests relevant to her comments.
Complications during pregnancy may be a wake-up call pointing to a higher risk for cardiovascular (CVD) and other diseases later in life. Therefore, the postpartum and interpregnancy periods are opportune windows for reducing CVD susceptibility and providing preventive care, especially for mothers with a history of adverse pregnancy outcomes (APOs). To that end, the American Heart Association recently released a scientific statement in Circulation outlining pregnancy-related CVD risks and reviewing evidence for preventive lifestyle strategies based on the AHA’s Life’s Essential 8 recommendations.
The Life’s Essential 8 encompass healthy eating, sleeping, and activity patterns; controlling weight, blood pressure, cholesterol, and blood sugar; and avoiding tobacco use.
“The motivation behind this statement was that complications in pregnancy are becoming more common and we now have more understanding that these serve as important risk factors for heart disease later in life,” said Jennifer Lewey, MD, MPH, director of the Penn Women’s Cardiovascular Health Program and an assistant professor of medicine at the University of Pennsylvania Perelman School of Medicine in Philadelphia.
“These risk factors are underrecognized and underappreciated. Clinicians don’t feel comfortable counseling their patients about how to reduce their cardiovascular disease risk,” Dr. Lewey, chair of the AHA writing group, said in an interview.
“So we thought this was the perfect time to highlight what we know and don’t know about how to care for this population,” she said.
APOs predispose mothers to heart disease and other long-term complications, including heart failure, stroke, chronic kidney disease, and vascular dementia. “Pregnancy is a significant stress on the body, and APOs such as preeclampsia can lead to vascular changes in the blood vessels and structural changes to the heart that can persist long term,” Dr. Lewey explained. Reduced maternal physical activity and unshed weight can compound the problem.
Varying by race and ethnicity, the proportion of mothers experiencing pregnancy complications, such as high blood pressure, gestational diabetes, and/or preterm birth is estimated at 10%-20%, the statement authors noted. These complications may serve as a wake-up call to young mothers.
The AHA panel believes that identifying at-risk women at younger ages will enable prevention through lifestyle changes and timely treatment. Little is known, however about what specific care may best reduce long-term CVD risk in women who had pregnancy complications, Dr. Lewey said. While randomized clinical trials have yet to evaluate the effects of postpartum interventions on CVD outcomes, the need for strategies supported by rigorous evidence is clear. “In particular, the fourth trimester, defined as the 12 weeks after delivery, is an optimal time to engage postpartum individuals in care to reduce maternal morbidity and improve care transitions,” the AHA group wrote.
An earlier AHA statement in 2021 recommended frequent cardiac risk factor screening in the first year postpartum at 6 and 12 weeks and again at 6 and 12 months, with appropriate transition from postpartum to longitudinal primary care around the 8- to 12-week mark.
Among the current statement’s findings: High blood pressure is the most prevalent cardiovascular condition during pregnancy, and the last two decades have seen a 25% increase in preeclampsia.
Hypertension during pregnancy carries a two- to fourfold higher risk of chronic hypertension within 2-7 years.
Women with one or more APOs experience heart attack and stroke at younger ages. Commenting on the statement but not involved in it, internist Natalie A. Cameron, MD, a primary and preventive care physician at Northwestern Medicine in Chicago, said, “This statement will be very helpful for physicians from a primary care perspective, especially since in internal medicine we don’t standardly receive education in cardiovascular health in the context of pregnancy and the first year postpartum.”
Dr. Cameron also noted that new research suggests the mother’s cardiovascular health during pregnancy can affect the child’s health through adolescence. “There’s a potential intergenerational effect and there may even be some programming and changes to the offspring in utero related to maternal lifestyle factors.”
While the postpartum period would seem like an opportune time to piggyback postpartum visits with infant wellness checkups, “the fact is that, in the U.S., many mothers are lost to care after delivery,” Dr. Lewey said. “But it’s essential to ensure transition to postpartum care.”
According to Dr. Cameron, physicians should be aware of the risk factor data and educate their pregnant and postpartum patients about reducing risk factors. “As I like to say, ‘If you’re going to take care of others, you need to take care of yourself first.’ ” While this statement may be a good starting point, future trials are needed to improve screening for subclinical CVD in individuals with APOs before symptom onset, the statement authors wrote.
This scientific statement was prepared on behalf of the American Heart Association. Dr. Lewey and several coauthors reported research funding from various agencies within the National Institutes of Health. Dr. Brown reported research funding from a cy-près court settlement with Wyeth. Dr. Cameron had no competing interests relevant to her comments.
Complications during pregnancy may be a wake-up call pointing to a higher risk for cardiovascular (CVD) and other diseases later in life. Therefore, the postpartum and interpregnancy periods are opportune windows for reducing CVD susceptibility and providing preventive care, especially for mothers with a history of adverse pregnancy outcomes (APOs). To that end, the American Heart Association recently released a scientific statement in Circulation outlining pregnancy-related CVD risks and reviewing evidence for preventive lifestyle strategies based on the AHA’s Life’s Essential 8 recommendations.
The Life’s Essential 8 encompass healthy eating, sleeping, and activity patterns; controlling weight, blood pressure, cholesterol, and blood sugar; and avoiding tobacco use.
“The motivation behind this statement was that complications in pregnancy are becoming more common and we now have more understanding that these serve as important risk factors for heart disease later in life,” said Jennifer Lewey, MD, MPH, director of the Penn Women’s Cardiovascular Health Program and an assistant professor of medicine at the University of Pennsylvania Perelman School of Medicine in Philadelphia.
“These risk factors are underrecognized and underappreciated. Clinicians don’t feel comfortable counseling their patients about how to reduce their cardiovascular disease risk,” Dr. Lewey, chair of the AHA writing group, said in an interview.
“So we thought this was the perfect time to highlight what we know and don’t know about how to care for this population,” she said.
APOs predispose mothers to heart disease and other long-term complications, including heart failure, stroke, chronic kidney disease, and vascular dementia. “Pregnancy is a significant stress on the body, and APOs such as preeclampsia can lead to vascular changes in the blood vessels and structural changes to the heart that can persist long term,” Dr. Lewey explained. Reduced maternal physical activity and unshed weight can compound the problem.
Varying by race and ethnicity, the proportion of mothers experiencing pregnancy complications, such as high blood pressure, gestational diabetes, and/or preterm birth is estimated at 10%-20%, the statement authors noted. These complications may serve as a wake-up call to young mothers.
The AHA panel believes that identifying at-risk women at younger ages will enable prevention through lifestyle changes and timely treatment. Little is known, however about what specific care may best reduce long-term CVD risk in women who had pregnancy complications, Dr. Lewey said. While randomized clinical trials have yet to evaluate the effects of postpartum interventions on CVD outcomes, the need for strategies supported by rigorous evidence is clear. “In particular, the fourth trimester, defined as the 12 weeks after delivery, is an optimal time to engage postpartum individuals in care to reduce maternal morbidity and improve care transitions,” the AHA group wrote.
An earlier AHA statement in 2021 recommended frequent cardiac risk factor screening in the first year postpartum at 6 and 12 weeks and again at 6 and 12 months, with appropriate transition from postpartum to longitudinal primary care around the 8- to 12-week mark.
Among the current statement’s findings: High blood pressure is the most prevalent cardiovascular condition during pregnancy, and the last two decades have seen a 25% increase in preeclampsia.
Hypertension during pregnancy carries a two- to fourfold higher risk of chronic hypertension within 2-7 years.
Women with one or more APOs experience heart attack and stroke at younger ages. Commenting on the statement but not involved in it, internist Natalie A. Cameron, MD, a primary and preventive care physician at Northwestern Medicine in Chicago, said, “This statement will be very helpful for physicians from a primary care perspective, especially since in internal medicine we don’t standardly receive education in cardiovascular health in the context of pregnancy and the first year postpartum.”
Dr. Cameron also noted that new research suggests the mother’s cardiovascular health during pregnancy can affect the child’s health through adolescence. “There’s a potential intergenerational effect and there may even be some programming and changes to the offspring in utero related to maternal lifestyle factors.”
While the postpartum period would seem like an opportune time to piggyback postpartum visits with infant wellness checkups, “the fact is that, in the U.S., many mothers are lost to care after delivery,” Dr. Lewey said. “But it’s essential to ensure transition to postpartum care.”
According to Dr. Cameron, physicians should be aware of the risk factor data and educate their pregnant and postpartum patients about reducing risk factors. “As I like to say, ‘If you’re going to take care of others, you need to take care of yourself first.’ ” While this statement may be a good starting point, future trials are needed to improve screening for subclinical CVD in individuals with APOs before symptom onset, the statement authors wrote.
This scientific statement was prepared on behalf of the American Heart Association. Dr. Lewey and several coauthors reported research funding from various agencies within the National Institutes of Health. Dr. Brown reported research funding from a cy-près court settlement with Wyeth. Dr. Cameron had no competing interests relevant to her comments.
FROM CIRCULATION
Should CRC Surveillance Extend Beyond 5 Years Post Surgery?
TOPLINE:
In patients with stages I-III colorectal cancer (CRC) who are cancer-free 5 years after surgery, the incidence of late recurrence or metachronous disease after 5 years is low and has decreased over time, new data showed.
METHODOLOGY:
- Recent treatment advances in CRC have reduced the likelihood that patients with nonmetastatic disease will recur or develop a second primary cancer more than 6 months after the first. Although late recurrences and metachronous CRC remain infrequent, it’s not clear if patients might benefit from longer term surveillance.
- To investigate whether extending surveillance beyond the recommended 5 years is beneficial, researchers assessed the incidence of late recurrence, metachronous CRC, and second primary cancers 5 years after surgical resection with curative intent.
- The researchers identified patients with stages I-III CRC, under age 80 years, from Danish healthcare registries who underwent surgical resection between January 2004 and December 2013.
- A total of 8883 patients were followed from 5 years after primary surgery until the date of recurrence, metachronous CRC, or second non-CRC primary cancer.
TAKEAWAY:
- Between 5 and 10 years after surgery, 370 survivors developed late recurrence (4.16%), 270 developed metachronous disease (3.0%), and 635 were diagnosed with a second primary cancer (7.15%).
- During 2009-2013 and 2004-2008, the risk for late recurrence decreased by 48% (5.6% vs 2.9%; subdistribution hazard ratio [sHR], 0.52) and the risk for metachronous disease decreased by 50% (4.1% vs 2.1%; sHR, 0.50).
- During the same timeframe, the risk for second non-CRC primary cancer remained unchanged (7.1% vs 7.1%; sHR, 0.98).
- Compared with patients diagnosed with late recurrences (46%), 5-year overall survival was higher for patients with metachronous CRC (72%; adjusted HR, 0.37) and slightly higher for those with second primary cancers (48%; adjusted HR, 0.78).
IN PRACTICE:
Because the incidences of late recurrence and metachronous CRC are low and decreased between 2004 and 2013, the data do not support extending CRC-specific surveillance beyond 5 years, the authors concluded. “Symptoms or suspicion of a cancer occurring 5-10 years from primary CRC treatment, is more likely to represent a non-CRC cancer (7.1%).”
SOURCE:
This study, led by Jesper Nors from Aarhus University Hospital, Aarhus, Denmark, was published on February 7, 2024, in the International Journal of Cancer.
LIMITATIONS:
Misclassification of a late recurrence or metachronous CRC could have affected the findings.
DISCLOSURES:
This work was funded by Institute of Clinical Medicine, Aarhus University, Denmark, Novo Nordisk Foundation, Innovation Fund Denmark, and the Danish Cancer Society. The authors reported no conflict of interests.
A version of this article appeared on Medscape.com.
TOPLINE:
In patients with stages I-III colorectal cancer (CRC) who are cancer-free 5 years after surgery, the incidence of late recurrence or metachronous disease after 5 years is low and has decreased over time, new data showed.
METHODOLOGY:
- Recent treatment advances in CRC have reduced the likelihood that patients with nonmetastatic disease will recur or develop a second primary cancer more than 6 months after the first. Although late recurrences and metachronous CRC remain infrequent, it’s not clear if patients might benefit from longer term surveillance.
- To investigate whether extending surveillance beyond the recommended 5 years is beneficial, researchers assessed the incidence of late recurrence, metachronous CRC, and second primary cancers 5 years after surgical resection with curative intent.
- The researchers identified patients with stages I-III CRC, under age 80 years, from Danish healthcare registries who underwent surgical resection between January 2004 and December 2013.
- A total of 8883 patients were followed from 5 years after primary surgery until the date of recurrence, metachronous CRC, or second non-CRC primary cancer.
TAKEAWAY:
- Between 5 and 10 years after surgery, 370 survivors developed late recurrence (4.16%), 270 developed metachronous disease (3.0%), and 635 were diagnosed with a second primary cancer (7.15%).
- During 2009-2013 and 2004-2008, the risk for late recurrence decreased by 48% (5.6% vs 2.9%; subdistribution hazard ratio [sHR], 0.52) and the risk for metachronous disease decreased by 50% (4.1% vs 2.1%; sHR, 0.50).
- During the same timeframe, the risk for second non-CRC primary cancer remained unchanged (7.1% vs 7.1%; sHR, 0.98).
- Compared with patients diagnosed with late recurrences (46%), 5-year overall survival was higher for patients with metachronous CRC (72%; adjusted HR, 0.37) and slightly higher for those with second primary cancers (48%; adjusted HR, 0.78).
IN PRACTICE:
Because the incidences of late recurrence and metachronous CRC are low and decreased between 2004 and 2013, the data do not support extending CRC-specific surveillance beyond 5 years, the authors concluded. “Symptoms or suspicion of a cancer occurring 5-10 years from primary CRC treatment, is more likely to represent a non-CRC cancer (7.1%).”
SOURCE:
This study, led by Jesper Nors from Aarhus University Hospital, Aarhus, Denmark, was published on February 7, 2024, in the International Journal of Cancer.
LIMITATIONS:
Misclassification of a late recurrence or metachronous CRC could have affected the findings.
DISCLOSURES:
This work was funded by Institute of Clinical Medicine, Aarhus University, Denmark, Novo Nordisk Foundation, Innovation Fund Denmark, and the Danish Cancer Society. The authors reported no conflict of interests.
A version of this article appeared on Medscape.com.
TOPLINE:
In patients with stages I-III colorectal cancer (CRC) who are cancer-free 5 years after surgery, the incidence of late recurrence or metachronous disease after 5 years is low and has decreased over time, new data showed.
METHODOLOGY:
- Recent treatment advances in CRC have reduced the likelihood that patients with nonmetastatic disease will recur or develop a second primary cancer more than 6 months after the first. Although late recurrences and metachronous CRC remain infrequent, it’s not clear if patients might benefit from longer term surveillance.
- To investigate whether extending surveillance beyond the recommended 5 years is beneficial, researchers assessed the incidence of late recurrence, metachronous CRC, and second primary cancers 5 years after surgical resection with curative intent.
- The researchers identified patients with stages I-III CRC, under age 80 years, from Danish healthcare registries who underwent surgical resection between January 2004 and December 2013.
- A total of 8883 patients were followed from 5 years after primary surgery until the date of recurrence, metachronous CRC, or second non-CRC primary cancer.
TAKEAWAY:
- Between 5 and 10 years after surgery, 370 survivors developed late recurrence (4.16%), 270 developed metachronous disease (3.0%), and 635 were diagnosed with a second primary cancer (7.15%).
- During 2009-2013 and 2004-2008, the risk for late recurrence decreased by 48% (5.6% vs 2.9%; subdistribution hazard ratio [sHR], 0.52) and the risk for metachronous disease decreased by 50% (4.1% vs 2.1%; sHR, 0.50).
- During the same timeframe, the risk for second non-CRC primary cancer remained unchanged (7.1% vs 7.1%; sHR, 0.98).
- Compared with patients diagnosed with late recurrences (46%), 5-year overall survival was higher for patients with metachronous CRC (72%; adjusted HR, 0.37) and slightly higher for those with second primary cancers (48%; adjusted HR, 0.78).
IN PRACTICE:
Because the incidences of late recurrence and metachronous CRC are low and decreased between 2004 and 2013, the data do not support extending CRC-specific surveillance beyond 5 years, the authors concluded. “Symptoms or suspicion of a cancer occurring 5-10 years from primary CRC treatment, is more likely to represent a non-CRC cancer (7.1%).”
SOURCE:
This study, led by Jesper Nors from Aarhus University Hospital, Aarhus, Denmark, was published on February 7, 2024, in the International Journal of Cancer.
LIMITATIONS:
Misclassification of a late recurrence or metachronous CRC could have affected the findings.
DISCLOSURES:
This work was funded by Institute of Clinical Medicine, Aarhus University, Denmark, Novo Nordisk Foundation, Innovation Fund Denmark, and the Danish Cancer Society. The authors reported no conflict of interests.
A version of this article appeared on Medscape.com.
Weight Management Therapies Work, But Utilization Low
TOPLINE:
A cohort study of primary care patients with obesity found significant associations between weight management treatments (WMTs) and ≥ 5% weight loss for individuals.
Yet, low WMT utilization hindered population-level benefit.
METHODOLOGY:
This retrospective, population-based cross-sectional cohort study included 149,959 primary care patients from a Michigan academic health system between October 2015 and March 2020.
TAKEAWAY:
- From 2017 to 2019, the average unadjusted body mass index (BMI) increased from 29.34 kg/m2 to 29.61 kg/m2 and the prevalence of obesity from 39.2% to 40.7%.
- Among 31,284 patients with obesity in 2017, 25.9% (6665) achieved ≥ 5% weight loss at 2 years.
- Among 37,245 with obesity in either 2017 or 2019 and sufficient follow-up, 1-year WMT utilization increased from 5.3% in 2017 to 7.1% in 2019 (difference, 1.7%; 95% CI, 1.3%-2.2%), including nutritional counseling (6.3%), weight loss medication prescriptions (2.6%), and bariatric surgery (1.0%).
- In two groups of n = 5090 with and without WMT exposure who were propensity score–matched on covariates including BMI, sex, and age, the probabilities of ≥ 5% weight loss at 1 year were 15.6% without WMTs, 23.1% for nutrition counseling, 54.6% for meal replacement, 27.8% for weight loss medication, and 93% for bariatric surgery, with all approaches significant compared to no WMTs.
IN PRACTICE:
“Health systems and insurers should consider novel strategies to enhance preference-sensitive use of WMT to optimize achievement of 5% or greater weight loss among individuals and populations with obesity.”
“While we included glucagon-like peptide 1 receptor agonists for type 2 diabetes, including semaglutide 1.0 mg, in our analyses, the study period predated the [US Food and Drug Administration]-approval of semaglutide 2.4 mg for weight management. Future work should explore the potential for semaglutide 2.4 mg and other medications with substantial weight loss effectiveness to reduce weight at the population level.”
SOURCE:
This study was conducted by James Henderson, PhD, of the Department of Internal Medicine, University of Michigan, Ann Arbor, Michigan, and colleagues and was published online in JAMA Network Open .
LIMITATIONS:
Single health system. Electronic health record data may be subject to weight and WMT measurement error, lack of adherence data, and any information about outside WMT access. Retrospective, observational study, subject to bias. Study period occurred before FDA approval of semaglutide for weight management, and thus, the findings may understate current use and effectiveness of weight loss medications.
DISCLOSURES:
The study was supported by grants from the National Institutes of Health and National Institute of Diabetes and Digestive and Kidney Diseases, Michigan Center for Diabetes Translational Research, Michigan Nutrition Obesity Research Center, and the Elizabeth Weiser Caswell Diabetes Institute at the University of Michigan. Dr. Henderson had no further disclosures, but some of the coauthors had industry ties.
A version of this article appeared on Medscape.com.
TOPLINE:
A cohort study of primary care patients with obesity found significant associations between weight management treatments (WMTs) and ≥ 5% weight loss for individuals.
Yet, low WMT utilization hindered population-level benefit.
METHODOLOGY:
This retrospective, population-based cross-sectional cohort study included 149,959 primary care patients from a Michigan academic health system between October 2015 and March 2020.
TAKEAWAY:
- From 2017 to 2019, the average unadjusted body mass index (BMI) increased from 29.34 kg/m2 to 29.61 kg/m2 and the prevalence of obesity from 39.2% to 40.7%.
- Among 31,284 patients with obesity in 2017, 25.9% (6665) achieved ≥ 5% weight loss at 2 years.
- Among 37,245 with obesity in either 2017 or 2019 and sufficient follow-up, 1-year WMT utilization increased from 5.3% in 2017 to 7.1% in 2019 (difference, 1.7%; 95% CI, 1.3%-2.2%), including nutritional counseling (6.3%), weight loss medication prescriptions (2.6%), and bariatric surgery (1.0%).
- In two groups of n = 5090 with and without WMT exposure who were propensity score–matched on covariates including BMI, sex, and age, the probabilities of ≥ 5% weight loss at 1 year were 15.6% without WMTs, 23.1% for nutrition counseling, 54.6% for meal replacement, 27.8% for weight loss medication, and 93% for bariatric surgery, with all approaches significant compared to no WMTs.
IN PRACTICE:
“Health systems and insurers should consider novel strategies to enhance preference-sensitive use of WMT to optimize achievement of 5% or greater weight loss among individuals and populations with obesity.”
“While we included glucagon-like peptide 1 receptor agonists for type 2 diabetes, including semaglutide 1.0 mg, in our analyses, the study period predated the [US Food and Drug Administration]-approval of semaglutide 2.4 mg for weight management. Future work should explore the potential for semaglutide 2.4 mg and other medications with substantial weight loss effectiveness to reduce weight at the population level.”
SOURCE:
This study was conducted by James Henderson, PhD, of the Department of Internal Medicine, University of Michigan, Ann Arbor, Michigan, and colleagues and was published online in JAMA Network Open .
LIMITATIONS:
Single health system. Electronic health record data may be subject to weight and WMT measurement error, lack of adherence data, and any information about outside WMT access. Retrospective, observational study, subject to bias. Study period occurred before FDA approval of semaglutide for weight management, and thus, the findings may understate current use and effectiveness of weight loss medications.
DISCLOSURES:
The study was supported by grants from the National Institutes of Health and National Institute of Diabetes and Digestive and Kidney Diseases, Michigan Center for Diabetes Translational Research, Michigan Nutrition Obesity Research Center, and the Elizabeth Weiser Caswell Diabetes Institute at the University of Michigan. Dr. Henderson had no further disclosures, but some of the coauthors had industry ties.
A version of this article appeared on Medscape.com.
TOPLINE:
A cohort study of primary care patients with obesity found significant associations between weight management treatments (WMTs) and ≥ 5% weight loss for individuals.
Yet, low WMT utilization hindered population-level benefit.
METHODOLOGY:
This retrospective, population-based cross-sectional cohort study included 149,959 primary care patients from a Michigan academic health system between October 2015 and March 2020.
TAKEAWAY:
- From 2017 to 2019, the average unadjusted body mass index (BMI) increased from 29.34 kg/m2 to 29.61 kg/m2 and the prevalence of obesity from 39.2% to 40.7%.
- Among 31,284 patients with obesity in 2017, 25.9% (6665) achieved ≥ 5% weight loss at 2 years.
- Among 37,245 with obesity in either 2017 or 2019 and sufficient follow-up, 1-year WMT utilization increased from 5.3% in 2017 to 7.1% in 2019 (difference, 1.7%; 95% CI, 1.3%-2.2%), including nutritional counseling (6.3%), weight loss medication prescriptions (2.6%), and bariatric surgery (1.0%).
- In two groups of n = 5090 with and without WMT exposure who were propensity score–matched on covariates including BMI, sex, and age, the probabilities of ≥ 5% weight loss at 1 year were 15.6% without WMTs, 23.1% for nutrition counseling, 54.6% for meal replacement, 27.8% for weight loss medication, and 93% for bariatric surgery, with all approaches significant compared to no WMTs.
IN PRACTICE:
“Health systems and insurers should consider novel strategies to enhance preference-sensitive use of WMT to optimize achievement of 5% or greater weight loss among individuals and populations with obesity.”
“While we included glucagon-like peptide 1 receptor agonists for type 2 diabetes, including semaglutide 1.0 mg, in our analyses, the study period predated the [US Food and Drug Administration]-approval of semaglutide 2.4 mg for weight management. Future work should explore the potential for semaglutide 2.4 mg and other medications with substantial weight loss effectiveness to reduce weight at the population level.”
SOURCE:
This study was conducted by James Henderson, PhD, of the Department of Internal Medicine, University of Michigan, Ann Arbor, Michigan, and colleagues and was published online in JAMA Network Open .
LIMITATIONS:
Single health system. Electronic health record data may be subject to weight and WMT measurement error, lack of adherence data, and any information about outside WMT access. Retrospective, observational study, subject to bias. Study period occurred before FDA approval of semaglutide for weight management, and thus, the findings may understate current use and effectiveness of weight loss medications.
DISCLOSURES:
The study was supported by grants from the National Institutes of Health and National Institute of Diabetes and Digestive and Kidney Diseases, Michigan Center for Diabetes Translational Research, Michigan Nutrition Obesity Research Center, and the Elizabeth Weiser Caswell Diabetes Institute at the University of Michigan. Dr. Henderson had no further disclosures, but some of the coauthors had industry ties.
A version of this article appeared on Medscape.com.
Obesity’s Effect on Neonatal Outcomes Is Dose Dependent
TOPLINE:
Higher body mass index (BMI) at the start of pregnancy is associated with increased risk for adverse maternal outcomes, including preeclampsia, and neonatal complications, such as respiratory distress syndrome (RDS), in a dose-dependent manner, new research shows.
METHODOLOGY:
- Researchers conducted a retrospective study of 58,497 singleton pregnancies delivered at an urban hospital between 2013 and 2021.
- They focused on pregnancies delivered between 24 and 42 weeks of gestation, for which information about BMI at the first prenatal visit was available.
- 21.1% of mothers had class I , 9.3% had class II obesity, and 6% had class III obesity.
TAKEAWAY:
- Obesity was associated with a dose-dependent increase in cesarean deliveries (27% of deliveries without obesity vs 46% of deliveries with class III obesity).
- Severe preeclampsia occurred in 8% of mothers without obesity and in 19% of mothers with class III obesity.
- Infants born to mothers with class III obesity were more likely than were infants born to mothers without obesity to have RDS, with a relative risk (RR) of 2.66.
- With class II obesity, the RR was 1.77. With class I obesity, the RR was 1.3.
- Obesity also was associated with increased risk for grade III-IV (RR), 4.58 for class III obesity) and (RR, 3.76).
IN PRACTICE:
“Infants born to patients with higher classes of obesity have significant associated morbidity including a 2 to 4 times increased risk of neonatal acidosis, grades III-IV intraventricular hemorrhage, sepsis, and RDS,” the researchers reported.
SOURCE:
Sara I. Jones, MD, with University of Texas Southwestern Medical Center in Dallas, presented the study on February 14 at the 2024 Pregnancy Meeting of the Society for Maternal-Fetal Medicine, in National Harbor, Maryland.
DISCLOSURES:
The researchers had no conflicts of interest to disclose.
A version of this article appeared on Medscape.com.
TOPLINE:
Higher body mass index (BMI) at the start of pregnancy is associated with increased risk for adverse maternal outcomes, including preeclampsia, and neonatal complications, such as respiratory distress syndrome (RDS), in a dose-dependent manner, new research shows.
METHODOLOGY:
- Researchers conducted a retrospective study of 58,497 singleton pregnancies delivered at an urban hospital between 2013 and 2021.
- They focused on pregnancies delivered between 24 and 42 weeks of gestation, for which information about BMI at the first prenatal visit was available.
- 21.1% of mothers had class I , 9.3% had class II obesity, and 6% had class III obesity.
TAKEAWAY:
- Obesity was associated with a dose-dependent increase in cesarean deliveries (27% of deliveries without obesity vs 46% of deliveries with class III obesity).
- Severe preeclampsia occurred in 8% of mothers without obesity and in 19% of mothers with class III obesity.
- Infants born to mothers with class III obesity were more likely than were infants born to mothers without obesity to have RDS, with a relative risk (RR) of 2.66.
- With class II obesity, the RR was 1.77. With class I obesity, the RR was 1.3.
- Obesity also was associated with increased risk for grade III-IV (RR), 4.58 for class III obesity) and (RR, 3.76).
IN PRACTICE:
“Infants born to patients with higher classes of obesity have significant associated morbidity including a 2 to 4 times increased risk of neonatal acidosis, grades III-IV intraventricular hemorrhage, sepsis, and RDS,” the researchers reported.
SOURCE:
Sara I. Jones, MD, with University of Texas Southwestern Medical Center in Dallas, presented the study on February 14 at the 2024 Pregnancy Meeting of the Society for Maternal-Fetal Medicine, in National Harbor, Maryland.
DISCLOSURES:
The researchers had no conflicts of interest to disclose.
A version of this article appeared on Medscape.com.
TOPLINE:
Higher body mass index (BMI) at the start of pregnancy is associated with increased risk for adverse maternal outcomes, including preeclampsia, and neonatal complications, such as respiratory distress syndrome (RDS), in a dose-dependent manner, new research shows.
METHODOLOGY:
- Researchers conducted a retrospective study of 58,497 singleton pregnancies delivered at an urban hospital between 2013 and 2021.
- They focused on pregnancies delivered between 24 and 42 weeks of gestation, for which information about BMI at the first prenatal visit was available.
- 21.1% of mothers had class I , 9.3% had class II obesity, and 6% had class III obesity.
TAKEAWAY:
- Obesity was associated with a dose-dependent increase in cesarean deliveries (27% of deliveries without obesity vs 46% of deliveries with class III obesity).
- Severe preeclampsia occurred in 8% of mothers without obesity and in 19% of mothers with class III obesity.
- Infants born to mothers with class III obesity were more likely than were infants born to mothers without obesity to have RDS, with a relative risk (RR) of 2.66.
- With class II obesity, the RR was 1.77. With class I obesity, the RR was 1.3.
- Obesity also was associated with increased risk for grade III-IV (RR), 4.58 for class III obesity) and (RR, 3.76).
IN PRACTICE:
“Infants born to patients with higher classes of obesity have significant associated morbidity including a 2 to 4 times increased risk of neonatal acidosis, grades III-IV intraventricular hemorrhage, sepsis, and RDS,” the researchers reported.
SOURCE:
Sara I. Jones, MD, with University of Texas Southwestern Medical Center in Dallas, presented the study on February 14 at the 2024 Pregnancy Meeting of the Society for Maternal-Fetal Medicine, in National Harbor, Maryland.
DISCLOSURES:
The researchers had no conflicts of interest to disclose.
A version of this article appeared on Medscape.com.
Parent-Led Digital CBT Effective for Childhood Anxiety
while substantially reducing cost and therapist time, new research showed.
In a randomized controlled trial, children participating in the program Online Support and Intervention (OSI) for Child Anxiety showed similar reductions in anxiety and improvements in daily functioning as peers receiving standard CBT.
“This study shows that by making the most of digital tools, we can deliver effective treatments more efficiently, helping services to better meet the growing demand for mental health services for children in ways that can also be more accessible for many families,” lead investigator Cathy Creswell, PhD, Departments of Experimental Psychology and Psychiatry, Oxford University, Oxford, England, told this news organization.
“I believe by incorporating this approach into standard care, we could address some of the major challenges faced by services and families,” Dr. Creswell added. “We are now moving the work out of the research environment into routine practice.”
The study was published online in The Lancet Psychiatry
Care Gaps for Common Problem
Anxiety is common in children, yet gaps exist between needed and available care, which investigators say could be filled by digitally augmented psychological treatments.
OSI, the digital platform used in the current study, was designed with therapists and families to aid parents in helping their children overcome problems with anxiety with remote therapist support.
The program provides parents with the core CBT content in accessible forms, including information in text, audio, and video and exercises supported by worksheets and quizzes.
There is also an optional child game app to help motivate the child to engage with the intervention. Parents are supported with weekly brief telephone or video call sessions with the therapist.
The two-arm randomized controlled non-inferiority trial included 444 families from 34 participating Child and Adolescent Mental Health Services (CAMHS) sites in England and Northern Ireland. Half received OSI plus therapist support and half CAMHS treatment as usual. The children were between 5 and 12 years old.
A total of 176 (79%) participants in the OSI plus therapist support group and 164 (74%) in the treatment as usual group completed the 26-week assessment.
‘Compelling’ Evidence
The primary clinical outcome was parent-reported interference caused by child anxiety at 26 weeks, using the Child Anxiety Impact Scale-Parent report.
On this measure, OSI plus therapist support was non-inferior to usual treatment, with a standardized mean difference of only 0.01 (95% CI, −0.15 to 0.17; P < .0001).
The intervention was also significantly non-inferior to usual treatment across all secondary outcomes, including total anxiety and depression scores, overall functioning, peer relationship problems, and prosocial behavior.
In addition, OSI plus therapist support was associated with nearly 60% less therapist time (182 min on average vs 307 min) and with lower costs than standard treatment. The OSI program was “likely to be cost-effective under several scenarios,” the researchers reported. Qualitative interviews showed “good” acceptability of the online program.
“This trial presents compelling clinical evidence and promising cost-effectiveness evidence that digitally augmented psychological therapies with therapist support can increase efficiencies in and access to child mental health services without compromising patient outcomes,” Dr. Creswell and colleagues concluded.
“Efforts are now needed to take full advantage of the opportunity that digitally augmented psychological treatments can bring to drive a step change in children’s mental health services, learning from successful examples of digital implementation elsewhere in health services,” they added.
‘Call to Action’
“We desperately need more trials” like this one, which showed the “clear value of a digitally augmented intervention over the usual face-to-face treatment” for child anxiety, wrote the authors of an accompanying editorial.
“Moreover, with the intervention delivered across 34 CAMHS settings in England and Northern Ireland, this study gives us confidence that the new intervention is effective in a range of clinical contexts at least in high-income countries and offers invaluable information about barriers and facilitators to future implementation,” wrote Sam Cartwright-Hatton, PhD, with the University of Sussex, Brighton and Hove, and Abby Dunn, PhD, with the University of Surrey, Guilford, England. “The potential benefits to overburdened services are clear.”
“That regular CAMHS clinicians, with minimal training and support from researchers, delivered the intervention within their standard caseload shows that it can be embedded within routine practice without a requirement for highly prepared and supervised clinicians,” they added.
However, more information is needed on the content and quality of the traditional CBT provided in the control group. It’s also important to determine if the program would be as effective with even less clinical support and in all types of childhood anxiety.
In addition, most clinicians in the OSI group only treated one patient with the new program and didn’t take advantage of the additional support offered by the research team, “which means we have not seen the true effectiveness of this intervention in the hands of well-practiced and well-trained staff,” Drs. Cartwright-Hatton and Dunn wrote.
Analyses included recruitment at the lower target amount, and one fifth of children were not offered treatment within the 12-week window recommended in the trial, they added.
“Although these issues place limits on the conclusions that can be drawn, they should also be seen as a call to action,” they wrote, adding that real-world clinical trials with greater clinician participation are needed. “All credit to this exceptional team for making this trial happen and for making it work as well as it did.”
The study was funded by the Department for Health and Social Care, UK Research and Innovation Research Grant, National Institute for Health and Care (NIHR) Research Policy Research Programme, Oxford and Thames Valley NIHR Applied Research Collaboration, and Oxford Health NIHR Biomedical Research Centre. Dr. Creswell is co-developer of the OSI platform and the author of a book for parents that is used in many of the participating clinical teams to augment treatment as usual for child anxiety problems and receives royalties from sales. Dr. Cartwright-Hatton and Dr. Dunn had no disclosures.
A version of this article appeared on Medscape.com.
while substantially reducing cost and therapist time, new research showed.
In a randomized controlled trial, children participating in the program Online Support and Intervention (OSI) for Child Anxiety showed similar reductions in anxiety and improvements in daily functioning as peers receiving standard CBT.
“This study shows that by making the most of digital tools, we can deliver effective treatments more efficiently, helping services to better meet the growing demand for mental health services for children in ways that can also be more accessible for many families,” lead investigator Cathy Creswell, PhD, Departments of Experimental Psychology and Psychiatry, Oxford University, Oxford, England, told this news organization.
“I believe by incorporating this approach into standard care, we could address some of the major challenges faced by services and families,” Dr. Creswell added. “We are now moving the work out of the research environment into routine practice.”
The study was published online in The Lancet Psychiatry
Care Gaps for Common Problem
Anxiety is common in children, yet gaps exist between needed and available care, which investigators say could be filled by digitally augmented psychological treatments.
OSI, the digital platform used in the current study, was designed with therapists and families to aid parents in helping their children overcome problems with anxiety with remote therapist support.
The program provides parents with the core CBT content in accessible forms, including information in text, audio, and video and exercises supported by worksheets and quizzes.
There is also an optional child game app to help motivate the child to engage with the intervention. Parents are supported with weekly brief telephone or video call sessions with the therapist.
The two-arm randomized controlled non-inferiority trial included 444 families from 34 participating Child and Adolescent Mental Health Services (CAMHS) sites in England and Northern Ireland. Half received OSI plus therapist support and half CAMHS treatment as usual. The children were between 5 and 12 years old.
A total of 176 (79%) participants in the OSI plus therapist support group and 164 (74%) in the treatment as usual group completed the 26-week assessment.
‘Compelling’ Evidence
The primary clinical outcome was parent-reported interference caused by child anxiety at 26 weeks, using the Child Anxiety Impact Scale-Parent report.
On this measure, OSI plus therapist support was non-inferior to usual treatment, with a standardized mean difference of only 0.01 (95% CI, −0.15 to 0.17; P < .0001).
The intervention was also significantly non-inferior to usual treatment across all secondary outcomes, including total anxiety and depression scores, overall functioning, peer relationship problems, and prosocial behavior.
In addition, OSI plus therapist support was associated with nearly 60% less therapist time (182 min on average vs 307 min) and with lower costs than standard treatment. The OSI program was “likely to be cost-effective under several scenarios,” the researchers reported. Qualitative interviews showed “good” acceptability of the online program.
“This trial presents compelling clinical evidence and promising cost-effectiveness evidence that digitally augmented psychological therapies with therapist support can increase efficiencies in and access to child mental health services without compromising patient outcomes,” Dr. Creswell and colleagues concluded.
“Efforts are now needed to take full advantage of the opportunity that digitally augmented psychological treatments can bring to drive a step change in children’s mental health services, learning from successful examples of digital implementation elsewhere in health services,” they added.
‘Call to Action’
“We desperately need more trials” like this one, which showed the “clear value of a digitally augmented intervention over the usual face-to-face treatment” for child anxiety, wrote the authors of an accompanying editorial.
“Moreover, with the intervention delivered across 34 CAMHS settings in England and Northern Ireland, this study gives us confidence that the new intervention is effective in a range of clinical contexts at least in high-income countries and offers invaluable information about barriers and facilitators to future implementation,” wrote Sam Cartwright-Hatton, PhD, with the University of Sussex, Brighton and Hove, and Abby Dunn, PhD, with the University of Surrey, Guilford, England. “The potential benefits to overburdened services are clear.”
“That regular CAMHS clinicians, with minimal training and support from researchers, delivered the intervention within their standard caseload shows that it can be embedded within routine practice without a requirement for highly prepared and supervised clinicians,” they added.
However, more information is needed on the content and quality of the traditional CBT provided in the control group. It’s also important to determine if the program would be as effective with even less clinical support and in all types of childhood anxiety.
In addition, most clinicians in the OSI group only treated one patient with the new program and didn’t take advantage of the additional support offered by the research team, “which means we have not seen the true effectiveness of this intervention in the hands of well-practiced and well-trained staff,” Drs. Cartwright-Hatton and Dunn wrote.
Analyses included recruitment at the lower target amount, and one fifth of children were not offered treatment within the 12-week window recommended in the trial, they added.
“Although these issues place limits on the conclusions that can be drawn, they should also be seen as a call to action,” they wrote, adding that real-world clinical trials with greater clinician participation are needed. “All credit to this exceptional team for making this trial happen and for making it work as well as it did.”
The study was funded by the Department for Health and Social Care, UK Research and Innovation Research Grant, National Institute for Health and Care (NIHR) Research Policy Research Programme, Oxford and Thames Valley NIHR Applied Research Collaboration, and Oxford Health NIHR Biomedical Research Centre. Dr. Creswell is co-developer of the OSI platform and the author of a book for parents that is used in many of the participating clinical teams to augment treatment as usual for child anxiety problems and receives royalties from sales. Dr. Cartwright-Hatton and Dr. Dunn had no disclosures.
A version of this article appeared on Medscape.com.
while substantially reducing cost and therapist time, new research showed.
In a randomized controlled trial, children participating in the program Online Support and Intervention (OSI) for Child Anxiety showed similar reductions in anxiety and improvements in daily functioning as peers receiving standard CBT.
“This study shows that by making the most of digital tools, we can deliver effective treatments more efficiently, helping services to better meet the growing demand for mental health services for children in ways that can also be more accessible for many families,” lead investigator Cathy Creswell, PhD, Departments of Experimental Psychology and Psychiatry, Oxford University, Oxford, England, told this news organization.
“I believe by incorporating this approach into standard care, we could address some of the major challenges faced by services and families,” Dr. Creswell added. “We are now moving the work out of the research environment into routine practice.”
The study was published online in The Lancet Psychiatry
Care Gaps for Common Problem
Anxiety is common in children, yet gaps exist between needed and available care, which investigators say could be filled by digitally augmented psychological treatments.
OSI, the digital platform used in the current study, was designed with therapists and families to aid parents in helping their children overcome problems with anxiety with remote therapist support.
The program provides parents with the core CBT content in accessible forms, including information in text, audio, and video and exercises supported by worksheets and quizzes.
There is also an optional child game app to help motivate the child to engage with the intervention. Parents are supported with weekly brief telephone or video call sessions with the therapist.
The two-arm randomized controlled non-inferiority trial included 444 families from 34 participating Child and Adolescent Mental Health Services (CAMHS) sites in England and Northern Ireland. Half received OSI plus therapist support and half CAMHS treatment as usual. The children were between 5 and 12 years old.
A total of 176 (79%) participants in the OSI plus therapist support group and 164 (74%) in the treatment as usual group completed the 26-week assessment.
‘Compelling’ Evidence
The primary clinical outcome was parent-reported interference caused by child anxiety at 26 weeks, using the Child Anxiety Impact Scale-Parent report.
On this measure, OSI plus therapist support was non-inferior to usual treatment, with a standardized mean difference of only 0.01 (95% CI, −0.15 to 0.17; P < .0001).
The intervention was also significantly non-inferior to usual treatment across all secondary outcomes, including total anxiety and depression scores, overall functioning, peer relationship problems, and prosocial behavior.
In addition, OSI plus therapist support was associated with nearly 60% less therapist time (182 min on average vs 307 min) and with lower costs than standard treatment. The OSI program was “likely to be cost-effective under several scenarios,” the researchers reported. Qualitative interviews showed “good” acceptability of the online program.
“This trial presents compelling clinical evidence and promising cost-effectiveness evidence that digitally augmented psychological therapies with therapist support can increase efficiencies in and access to child mental health services without compromising patient outcomes,” Dr. Creswell and colleagues concluded.
“Efforts are now needed to take full advantage of the opportunity that digitally augmented psychological treatments can bring to drive a step change in children’s mental health services, learning from successful examples of digital implementation elsewhere in health services,” they added.
‘Call to Action’
“We desperately need more trials” like this one, which showed the “clear value of a digitally augmented intervention over the usual face-to-face treatment” for child anxiety, wrote the authors of an accompanying editorial.
“Moreover, with the intervention delivered across 34 CAMHS settings in England and Northern Ireland, this study gives us confidence that the new intervention is effective in a range of clinical contexts at least in high-income countries and offers invaluable information about barriers and facilitators to future implementation,” wrote Sam Cartwright-Hatton, PhD, with the University of Sussex, Brighton and Hove, and Abby Dunn, PhD, with the University of Surrey, Guilford, England. “The potential benefits to overburdened services are clear.”
“That regular CAMHS clinicians, with minimal training and support from researchers, delivered the intervention within their standard caseload shows that it can be embedded within routine practice without a requirement for highly prepared and supervised clinicians,” they added.
However, more information is needed on the content and quality of the traditional CBT provided in the control group. It’s also important to determine if the program would be as effective with even less clinical support and in all types of childhood anxiety.
In addition, most clinicians in the OSI group only treated one patient with the new program and didn’t take advantage of the additional support offered by the research team, “which means we have not seen the true effectiveness of this intervention in the hands of well-practiced and well-trained staff,” Drs. Cartwright-Hatton and Dunn wrote.
Analyses included recruitment at the lower target amount, and one fifth of children were not offered treatment within the 12-week window recommended in the trial, they added.
“Although these issues place limits on the conclusions that can be drawn, they should also be seen as a call to action,” they wrote, adding that real-world clinical trials with greater clinician participation are needed. “All credit to this exceptional team for making this trial happen and for making it work as well as it did.”
The study was funded by the Department for Health and Social Care, UK Research and Innovation Research Grant, National Institute for Health and Care (NIHR) Research Policy Research Programme, Oxford and Thames Valley NIHR Applied Research Collaboration, and Oxford Health NIHR Biomedical Research Centre. Dr. Creswell is co-developer of the OSI platform and the author of a book for parents that is used in many of the participating clinical teams to augment treatment as usual for child anxiety problems and receives royalties from sales. Dr. Cartwright-Hatton and Dr. Dunn had no disclosures.
A version of this article appeared on Medscape.com.
FROM THE LANCET PSYCHIATRY
Kimchi: Not Magically Protective Against Weight Gain
How much of societal diet-related scientific illiteracy can be blamed on the publication decisions of medical journals around food studies?
That was the question I pondered when reading “Association between kimchi consumption and obesity based on BMI and abdominal obesity in Korean adults: a cross-sectional analysis of the Health Examinees study,” recently published in BMJ Open. Although I will get to the study particulars momentarily, that it’s 2024 and journals are still publishing cross-sectional studies of the impact of a single food’s subjectively reported consumption on health outcomes is mind boggling.
You might wonder why I wasn’t mind boggled by the authors rather than the journal — but the authors’ interest in publishing a study on kimchi’s supposed impact on obesity is an easy thing to explain, in that the study was funded by the World Institute of Kimchi, where two of its four authors are employed.
You might also wonder why I wasn’t mind boggled by media running with this story — but the media’s job is to capture eyeballs, and who doesn’t love a good magic food story, doubly so for one involving obesity and one with a study backing it up?
Back to this World Institute of Kimchi project looking at kimchi intake on obesity rates. No doubt if I worked for the World Institute of Kimchi, I would want kimchi to be shown to be somehow magically protective against weight gain. So how might I go about exploring that?
Well, I could look to the data from the Health Examinees (HEXA) Study. The HEXA study was a cross-sectional look at South Koreans; included in their data collection was a 106-item food frequency questionnaire (FFQ).
That questionnaire looked at 106 food items — yep, you guessed it, explicitly including kimchi. Not included in this FFQ, though, were prepared foods, meaning that it was unable to measure seasonings, spices, or cooking oils. Also perhaps problematic is that no doubt most of us consume more than 106 total food items in our diets. Perhaps this is why the validation study of HEXA’s food item–based FFQ found that it had “relatively low validity” when compared against 12-day food diaries and why its creators themselves report it to be in their study’s conclusion only “reasonably acceptable” to apply to a population. But yes, kimchi!
So for the sake of this exercise, though, let’s assume that instead of only a reasonably acceptable FFQ with low validity, the FFQ was fantastic and its data robust. How great then is kimchi at preventing obesity? Certainly, the media report it’s pretty darn good. Here’s a smattering from the literal dozens of headlines of stories covering this paper:
Eating kimchi every day could help stave off weight gain, new study says — NBC News
Eating kimchi every day may prevent weight gain, research suggests — Sky News
Want to avoid piling on the pounds? Try kimchi for breakfast — The Telegraph
But when we turn to the paper itself, suddenly things aren’t so clear.
According to the paper, men who reported eating two to three servings of kimchi per day were found to have lower rates of obesity, whereas men who reported eating three to five servings of kimchi per day were not. But these are overlapping groups! Also found was that men consuming more than five servings of kimchi per day have higher rates of obesity. When taken together, these findings do not demonstrate a statistically significant trend of kimchi intake on obesity in men. Whereas in women, things are worse in that the more kimchi reportedly consumed, the more obesity, in a trend that did (just) reach statistical significance.
So even if we pretend the FFQs were robust enough to make conclusions about a single food’s impact on obesity, and we pretend there was a well-described, plausible mechanistic reason to believe same (there isn’t), and we pretend that this particular FFQ had better than “relatively low validity,” there is no conclusion here to be drawn about kimchi’s impact on obesity.
What we can conclude is that when it comes to publishing papers purporting to find the impact of single foods on obesity, journals will still happily publish them and their publication will lead to hyperbolic headlines and stories, which in turn reinforce the scientifically illiterate notion that the highly complex multifactorial problem of obesity boils down to simple food choices, which in turn keeps weight loss grifters everywhere in business while fueling societal weight bias.
Dr. Freedhoff is Associate Professor, Department of Family Medicine, University of Ottawa; Medical Director, Bariatric Medical Institute, Ottawa, Ontario, Canada. He disclosed ties with Bariatric Medical Institute, Constant Health, and Novo Nordisk.
A version of this article appeared on Medscape.com.
How much of societal diet-related scientific illiteracy can be blamed on the publication decisions of medical journals around food studies?
That was the question I pondered when reading “Association between kimchi consumption and obesity based on BMI and abdominal obesity in Korean adults: a cross-sectional analysis of the Health Examinees study,” recently published in BMJ Open. Although I will get to the study particulars momentarily, that it’s 2024 and journals are still publishing cross-sectional studies of the impact of a single food’s subjectively reported consumption on health outcomes is mind boggling.
You might wonder why I wasn’t mind boggled by the authors rather than the journal — but the authors’ interest in publishing a study on kimchi’s supposed impact on obesity is an easy thing to explain, in that the study was funded by the World Institute of Kimchi, where two of its four authors are employed.
You might also wonder why I wasn’t mind boggled by media running with this story — but the media’s job is to capture eyeballs, and who doesn’t love a good magic food story, doubly so for one involving obesity and one with a study backing it up?
Back to this World Institute of Kimchi project looking at kimchi intake on obesity rates. No doubt if I worked for the World Institute of Kimchi, I would want kimchi to be shown to be somehow magically protective against weight gain. So how might I go about exploring that?
Well, I could look to the data from the Health Examinees (HEXA) Study. The HEXA study was a cross-sectional look at South Koreans; included in their data collection was a 106-item food frequency questionnaire (FFQ).
That questionnaire looked at 106 food items — yep, you guessed it, explicitly including kimchi. Not included in this FFQ, though, were prepared foods, meaning that it was unable to measure seasonings, spices, or cooking oils. Also perhaps problematic is that no doubt most of us consume more than 106 total food items in our diets. Perhaps this is why the validation study of HEXA’s food item–based FFQ found that it had “relatively low validity” when compared against 12-day food diaries and why its creators themselves report it to be in their study’s conclusion only “reasonably acceptable” to apply to a population. But yes, kimchi!
So for the sake of this exercise, though, let’s assume that instead of only a reasonably acceptable FFQ with low validity, the FFQ was fantastic and its data robust. How great then is kimchi at preventing obesity? Certainly, the media report it’s pretty darn good. Here’s a smattering from the literal dozens of headlines of stories covering this paper:
Eating kimchi every day could help stave off weight gain, new study says — NBC News
Eating kimchi every day may prevent weight gain, research suggests — Sky News
Want to avoid piling on the pounds? Try kimchi for breakfast — The Telegraph
But when we turn to the paper itself, suddenly things aren’t so clear.
According to the paper, men who reported eating two to three servings of kimchi per day were found to have lower rates of obesity, whereas men who reported eating three to five servings of kimchi per day were not. But these are overlapping groups! Also found was that men consuming more than five servings of kimchi per day have higher rates of obesity. When taken together, these findings do not demonstrate a statistically significant trend of kimchi intake on obesity in men. Whereas in women, things are worse in that the more kimchi reportedly consumed, the more obesity, in a trend that did (just) reach statistical significance.
So even if we pretend the FFQs were robust enough to make conclusions about a single food’s impact on obesity, and we pretend there was a well-described, plausible mechanistic reason to believe same (there isn’t), and we pretend that this particular FFQ had better than “relatively low validity,” there is no conclusion here to be drawn about kimchi’s impact on obesity.
What we can conclude is that when it comes to publishing papers purporting to find the impact of single foods on obesity, journals will still happily publish them and their publication will lead to hyperbolic headlines and stories, which in turn reinforce the scientifically illiterate notion that the highly complex multifactorial problem of obesity boils down to simple food choices, which in turn keeps weight loss grifters everywhere in business while fueling societal weight bias.
Dr. Freedhoff is Associate Professor, Department of Family Medicine, University of Ottawa; Medical Director, Bariatric Medical Institute, Ottawa, Ontario, Canada. He disclosed ties with Bariatric Medical Institute, Constant Health, and Novo Nordisk.
A version of this article appeared on Medscape.com.
How much of societal diet-related scientific illiteracy can be blamed on the publication decisions of medical journals around food studies?
That was the question I pondered when reading “Association between kimchi consumption and obesity based on BMI and abdominal obesity in Korean adults: a cross-sectional analysis of the Health Examinees study,” recently published in BMJ Open. Although I will get to the study particulars momentarily, that it’s 2024 and journals are still publishing cross-sectional studies of the impact of a single food’s subjectively reported consumption on health outcomes is mind boggling.
You might wonder why I wasn’t mind boggled by the authors rather than the journal — but the authors’ interest in publishing a study on kimchi’s supposed impact on obesity is an easy thing to explain, in that the study was funded by the World Institute of Kimchi, where two of its four authors are employed.
You might also wonder why I wasn’t mind boggled by media running with this story — but the media’s job is to capture eyeballs, and who doesn’t love a good magic food story, doubly so for one involving obesity and one with a study backing it up?
Back to this World Institute of Kimchi project looking at kimchi intake on obesity rates. No doubt if I worked for the World Institute of Kimchi, I would want kimchi to be shown to be somehow magically protective against weight gain. So how might I go about exploring that?
Well, I could look to the data from the Health Examinees (HEXA) Study. The HEXA study was a cross-sectional look at South Koreans; included in their data collection was a 106-item food frequency questionnaire (FFQ).
That questionnaire looked at 106 food items — yep, you guessed it, explicitly including kimchi. Not included in this FFQ, though, were prepared foods, meaning that it was unable to measure seasonings, spices, or cooking oils. Also perhaps problematic is that no doubt most of us consume more than 106 total food items in our diets. Perhaps this is why the validation study of HEXA’s food item–based FFQ found that it had “relatively low validity” when compared against 12-day food diaries and why its creators themselves report it to be in their study’s conclusion only “reasonably acceptable” to apply to a population. But yes, kimchi!
So for the sake of this exercise, though, let’s assume that instead of only a reasonably acceptable FFQ with low validity, the FFQ was fantastic and its data robust. How great then is kimchi at preventing obesity? Certainly, the media report it’s pretty darn good. Here’s a smattering from the literal dozens of headlines of stories covering this paper:
Eating kimchi every day could help stave off weight gain, new study says — NBC News
Eating kimchi every day may prevent weight gain, research suggests — Sky News
Want to avoid piling on the pounds? Try kimchi for breakfast — The Telegraph
But when we turn to the paper itself, suddenly things aren’t so clear.
According to the paper, men who reported eating two to three servings of kimchi per day were found to have lower rates of obesity, whereas men who reported eating three to five servings of kimchi per day were not. But these are overlapping groups! Also found was that men consuming more than five servings of kimchi per day have higher rates of obesity. When taken together, these findings do not demonstrate a statistically significant trend of kimchi intake on obesity in men. Whereas in women, things are worse in that the more kimchi reportedly consumed, the more obesity, in a trend that did (just) reach statistical significance.
So even if we pretend the FFQs were robust enough to make conclusions about a single food’s impact on obesity, and we pretend there was a well-described, plausible mechanistic reason to believe same (there isn’t), and we pretend that this particular FFQ had better than “relatively low validity,” there is no conclusion here to be drawn about kimchi’s impact on obesity.
What we can conclude is that when it comes to publishing papers purporting to find the impact of single foods on obesity, journals will still happily publish them and their publication will lead to hyperbolic headlines and stories, which in turn reinforce the scientifically illiterate notion that the highly complex multifactorial problem of obesity boils down to simple food choices, which in turn keeps weight loss grifters everywhere in business while fueling societal weight bias.
Dr. Freedhoff is Associate Professor, Department of Family Medicine, University of Ottawa; Medical Director, Bariatric Medical Institute, Ottawa, Ontario, Canada. He disclosed ties with Bariatric Medical Institute, Constant Health, and Novo Nordisk.
A version of this article appeared on Medscape.com.
Lying-in No Longer: Staying Active Key to Healthy Pregnancy
A trio of studies (abstracts 1101, 1079, and 944) presented on February 14 at the meeting sponsored by the Society for Maternal-Fetal Medicine point to the power of staying physically active during pregnancy. The work highlights the beneficial effects of exercise on a variety of outcomes, including depression, anxiety, and reducing the rate of cesarean deliveries.
“Twenty-plus years ago, there were so many recommendations for bed rest in pregnancy,” said Danielle Panelli, MD, a maternal-fetal medicine physician and research scholar at Stanford University in Stanford, California. “We’ve really come full circle on that.” The American College of Obstetricians and Gynecologists recommends pregnant people get at least 150 minutes of moderate activity or 75 minutes of vigorous activity per week.
Dr. Panelli and colleagues looked at the association of physical activity and anxiety among three groups of pregnant people: 20 outpatients from low-risk obstetric clinics, 20 outpatients from high-risk obstetric clinics, and 19 inpatients. Participants wore accelerometer watches for up to seven days to measure physical activity. The primary outcome was mean daily step count, with secondary outcomes including metabolic equivalent tasks (METs), moderate to vigorous physical activity (MVPA), and anxiety as measured using the State-Trait Anxiety Inventory.
Low-risk outpatients had an average daily step count of 9090 compared with high-risk outpatients at 8898 and inpatients at 6493. Compared with outpatients, inpatients also had significantly lower METs (adjusted beta, -0.20; 95% CI -0.26 to -0.13; P < .001), and MVPAs (adjusted beta, -43.6; 95% CI, -61.2 to -25.9; P < .001). Over the course of a week, steps progressively decreased for inpatients but not for women in either of the outpatient groups. Among the entire cohort, lower step counts correlated with higher anxiety scores (r = 0.30; P = .02).
“These results highlight the need for physical activity interventions, particularly for hospitalized pregnant people,” Dr. Panelli said. That could be something as simple as asking patients to walk three laps around the unit per day, she suggested.
A second study investigated the effect of physical activity during pregnancy on peripartum depression. Researchers at the University of Alabama at Birmingham reviewed data from participants in nuMoM2b, a large cohort study of pregnant women who would be delivering for the first time and had at least one medical comorbidity, such as chronic hypertension, asthma, or cardiac disease. The investigators looked at activity logs maintained by study participants and turned in at three study visits: 6-13.6 weeks, 14-21.6 weeks, and 22-29.6 weeks.
Being physically active was associated with 15% lower odds of having an Edinburgh Postnatal Depression Score (EPDS) > 10 (adjusted odds ratio, 0.85; 95% CI, 0.72-0.99). Nine percent of people in the active group and 12% of people in the nonactive group had an EPDS > 10, which is suggestive of depression. However, a change in EPDS from visit one to three and treatment for perinatal depression did not differ by physical activity.
“One of the interesting findings are that we didn’t see any safety signals [from exercise], so there wasn’t an increase in suspected fetal growth restriction or low fluid or preterm birth, or actual birthweight being low in the people who were active,” said Charlotte McCarley, MD, a maternal-fetal medicine fellow at the University of Alabama at Birmingham, who led the research. “A lot of studies have been done that have looked at prospective exercise in pregnancy, but they exclude the cohort that we looked at for concern that there may be a safety issue.”
In a third study, researchers at the Rambam Health Care Campus in Haifa, Israel, looked at the effect of physical activity on mode of delivery. The prospective observational analysis included 401 women with singleton pregnancies attempting vaginal deliveries.
The researchers tracked the number of daily steps taken during gestation using validated phone apps. They adjusted their findings for age, parity, body mass index, and medical and obstetric history.
The investigators observed a gradual decrease in physical activity as pregnancy progressed (mean of 3184 steps in the first trimester, 2700 steps in mid-pregnancy, and 2152 steps in the third trimester). The overall incidence of cesarean delivery was 10.5%. However, women who were more active during pregnancy had a significantly lower incidence of cesarean delivery.
Area under the ROC curve, with a cut-off of 2093.5 daily steps, was 0.694 (95% CI, 0.615-0.773), resulting in a significant risk reduction in a 78% reduction in the rate of cesarean surgery (odds ratio, 0.22; 95% CI, 0.104-0.465).
More active patients also had a reduced composite outcome of gestational diabetes, gestational hypertension, and preeclampsia; less use of epidural analgesia during labor; and less postpartum hemorrhage. Preterm birth, labor induction, neonatal weight, and admission to the neonatal intensive care unit were not significantly affected, the researchers reported.
“Maintaining an active lifestyle during pregnancy should be strongly encouraged,” they wrote.
The investigators disclosed no relevant financial relationships.
A version of this article appeared on Medscape.com.
A trio of studies (abstracts 1101, 1079, and 944) presented on February 14 at the meeting sponsored by the Society for Maternal-Fetal Medicine point to the power of staying physically active during pregnancy. The work highlights the beneficial effects of exercise on a variety of outcomes, including depression, anxiety, and reducing the rate of cesarean deliveries.
“Twenty-plus years ago, there were so many recommendations for bed rest in pregnancy,” said Danielle Panelli, MD, a maternal-fetal medicine physician and research scholar at Stanford University in Stanford, California. “We’ve really come full circle on that.” The American College of Obstetricians and Gynecologists recommends pregnant people get at least 150 minutes of moderate activity or 75 minutes of vigorous activity per week.
Dr. Panelli and colleagues looked at the association of physical activity and anxiety among three groups of pregnant people: 20 outpatients from low-risk obstetric clinics, 20 outpatients from high-risk obstetric clinics, and 19 inpatients. Participants wore accelerometer watches for up to seven days to measure physical activity. The primary outcome was mean daily step count, with secondary outcomes including metabolic equivalent tasks (METs), moderate to vigorous physical activity (MVPA), and anxiety as measured using the State-Trait Anxiety Inventory.
Low-risk outpatients had an average daily step count of 9090 compared with high-risk outpatients at 8898 and inpatients at 6493. Compared with outpatients, inpatients also had significantly lower METs (adjusted beta, -0.20; 95% CI -0.26 to -0.13; P < .001), and MVPAs (adjusted beta, -43.6; 95% CI, -61.2 to -25.9; P < .001). Over the course of a week, steps progressively decreased for inpatients but not for women in either of the outpatient groups. Among the entire cohort, lower step counts correlated with higher anxiety scores (r = 0.30; P = .02).
“These results highlight the need for physical activity interventions, particularly for hospitalized pregnant people,” Dr. Panelli said. That could be something as simple as asking patients to walk three laps around the unit per day, she suggested.
A second study investigated the effect of physical activity during pregnancy on peripartum depression. Researchers at the University of Alabama at Birmingham reviewed data from participants in nuMoM2b, a large cohort study of pregnant women who would be delivering for the first time and had at least one medical comorbidity, such as chronic hypertension, asthma, or cardiac disease. The investigators looked at activity logs maintained by study participants and turned in at three study visits: 6-13.6 weeks, 14-21.6 weeks, and 22-29.6 weeks.
Being physically active was associated with 15% lower odds of having an Edinburgh Postnatal Depression Score (EPDS) > 10 (adjusted odds ratio, 0.85; 95% CI, 0.72-0.99). Nine percent of people in the active group and 12% of people in the nonactive group had an EPDS > 10, which is suggestive of depression. However, a change in EPDS from visit one to three and treatment for perinatal depression did not differ by physical activity.
“One of the interesting findings are that we didn’t see any safety signals [from exercise], so there wasn’t an increase in suspected fetal growth restriction or low fluid or preterm birth, or actual birthweight being low in the people who were active,” said Charlotte McCarley, MD, a maternal-fetal medicine fellow at the University of Alabama at Birmingham, who led the research. “A lot of studies have been done that have looked at prospective exercise in pregnancy, but they exclude the cohort that we looked at for concern that there may be a safety issue.”
In a third study, researchers at the Rambam Health Care Campus in Haifa, Israel, looked at the effect of physical activity on mode of delivery. The prospective observational analysis included 401 women with singleton pregnancies attempting vaginal deliveries.
The researchers tracked the number of daily steps taken during gestation using validated phone apps. They adjusted their findings for age, parity, body mass index, and medical and obstetric history.
The investigators observed a gradual decrease in physical activity as pregnancy progressed (mean of 3184 steps in the first trimester, 2700 steps in mid-pregnancy, and 2152 steps in the third trimester). The overall incidence of cesarean delivery was 10.5%. However, women who were more active during pregnancy had a significantly lower incidence of cesarean delivery.
Area under the ROC curve, with a cut-off of 2093.5 daily steps, was 0.694 (95% CI, 0.615-0.773), resulting in a significant risk reduction in a 78% reduction in the rate of cesarean surgery (odds ratio, 0.22; 95% CI, 0.104-0.465).
More active patients also had a reduced composite outcome of gestational diabetes, gestational hypertension, and preeclampsia; less use of epidural analgesia during labor; and less postpartum hemorrhage. Preterm birth, labor induction, neonatal weight, and admission to the neonatal intensive care unit were not significantly affected, the researchers reported.
“Maintaining an active lifestyle during pregnancy should be strongly encouraged,” they wrote.
The investigators disclosed no relevant financial relationships.
A version of this article appeared on Medscape.com.
A trio of studies (abstracts 1101, 1079, and 944) presented on February 14 at the meeting sponsored by the Society for Maternal-Fetal Medicine point to the power of staying physically active during pregnancy. The work highlights the beneficial effects of exercise on a variety of outcomes, including depression, anxiety, and reducing the rate of cesarean deliveries.
“Twenty-plus years ago, there were so many recommendations for bed rest in pregnancy,” said Danielle Panelli, MD, a maternal-fetal medicine physician and research scholar at Stanford University in Stanford, California. “We’ve really come full circle on that.” The American College of Obstetricians and Gynecologists recommends pregnant people get at least 150 minutes of moderate activity or 75 minutes of vigorous activity per week.
Dr. Panelli and colleagues looked at the association of physical activity and anxiety among three groups of pregnant people: 20 outpatients from low-risk obstetric clinics, 20 outpatients from high-risk obstetric clinics, and 19 inpatients. Participants wore accelerometer watches for up to seven days to measure physical activity. The primary outcome was mean daily step count, with secondary outcomes including metabolic equivalent tasks (METs), moderate to vigorous physical activity (MVPA), and anxiety as measured using the State-Trait Anxiety Inventory.
Low-risk outpatients had an average daily step count of 9090 compared with high-risk outpatients at 8898 and inpatients at 6493. Compared with outpatients, inpatients also had significantly lower METs (adjusted beta, -0.20; 95% CI -0.26 to -0.13; P < .001), and MVPAs (adjusted beta, -43.6; 95% CI, -61.2 to -25.9; P < .001). Over the course of a week, steps progressively decreased for inpatients but not for women in either of the outpatient groups. Among the entire cohort, lower step counts correlated with higher anxiety scores (r = 0.30; P = .02).
“These results highlight the need for physical activity interventions, particularly for hospitalized pregnant people,” Dr. Panelli said. That could be something as simple as asking patients to walk three laps around the unit per day, she suggested.
A second study investigated the effect of physical activity during pregnancy on peripartum depression. Researchers at the University of Alabama at Birmingham reviewed data from participants in nuMoM2b, a large cohort study of pregnant women who would be delivering for the first time and had at least one medical comorbidity, such as chronic hypertension, asthma, or cardiac disease. The investigators looked at activity logs maintained by study participants and turned in at three study visits: 6-13.6 weeks, 14-21.6 weeks, and 22-29.6 weeks.
Being physically active was associated with 15% lower odds of having an Edinburgh Postnatal Depression Score (EPDS) > 10 (adjusted odds ratio, 0.85; 95% CI, 0.72-0.99). Nine percent of people in the active group and 12% of people in the nonactive group had an EPDS > 10, which is suggestive of depression. However, a change in EPDS from visit one to three and treatment for perinatal depression did not differ by physical activity.
“One of the interesting findings are that we didn’t see any safety signals [from exercise], so there wasn’t an increase in suspected fetal growth restriction or low fluid or preterm birth, or actual birthweight being low in the people who were active,” said Charlotte McCarley, MD, a maternal-fetal medicine fellow at the University of Alabama at Birmingham, who led the research. “A lot of studies have been done that have looked at prospective exercise in pregnancy, but they exclude the cohort that we looked at for concern that there may be a safety issue.”
In a third study, researchers at the Rambam Health Care Campus in Haifa, Israel, looked at the effect of physical activity on mode of delivery. The prospective observational analysis included 401 women with singleton pregnancies attempting vaginal deliveries.
The researchers tracked the number of daily steps taken during gestation using validated phone apps. They adjusted their findings for age, parity, body mass index, and medical and obstetric history.
The investigators observed a gradual decrease in physical activity as pregnancy progressed (mean of 3184 steps in the first trimester, 2700 steps in mid-pregnancy, and 2152 steps in the third trimester). The overall incidence of cesarean delivery was 10.5%. However, women who were more active during pregnancy had a significantly lower incidence of cesarean delivery.
Area under the ROC curve, with a cut-off of 2093.5 daily steps, was 0.694 (95% CI, 0.615-0.773), resulting in a significant risk reduction in a 78% reduction in the rate of cesarean surgery (odds ratio, 0.22; 95% CI, 0.104-0.465).
More active patients also had a reduced composite outcome of gestational diabetes, gestational hypertension, and preeclampsia; less use of epidural analgesia during labor; and less postpartum hemorrhage. Preterm birth, labor induction, neonatal weight, and admission to the neonatal intensive care unit were not significantly affected, the researchers reported.
“Maintaining an active lifestyle during pregnancy should be strongly encouraged,” they wrote.
The investigators disclosed no relevant financial relationships.
A version of this article appeared on Medscape.com.
FROM THE PREGNANCY MEETING
Undiagnosed Cirrhosis May Underlie Some Dementia Cases
Cognitive impairment in some US veterans may be due to treatable hepatic encephalopathy (HE) rather than dementia, new research suggested.
From 5%-10% of veterans diagnosed with dementia had possible undiagnosed cirrhosis, implicating HE as a contributor to cognitive impairment, found the study by Jasmohan S. Bajaj, MD, of Virginia Commonwealth University and Richmond VA Medical Center, Virginia, and colleagues.
The research was prompted, in part, by an earlier case study by Dr. Bajaj and colleagues that showed that two older men diagnosed with dementia and Parkinson’s disease actually had HE, meaning their symptoms were due to advanced but treatable liver disease.
It’s not that clinicians don’t know how to treat HE; the problem was that they did not suspect it.”
Among veterans with cirrhosis, concomitant dementia is common and is difficult to distinguish from HE, but the extent to which patients with dementia also have undiagnosed cirrhosis and HE is unknown, the authors of the current study wrote. “Undiagnosed cirrhosis among veterans with dementia could raise the possibility that part of their cognitive impairment may be due to reversible HE,” they added.
To investigate, the researchers examined the prevalence and risk factors of undiagnosed cirrhosis — and therefore, possible HE — among US veterans.
The study was published online in JAMA Network Open.
Dementia or Cirrhosis?
Using the VHA Corporate Data Warehouse, researchers analyzed medical records of 177,422 US veterans diagnosed with dementia but not cirrhosis between 2009 and 2019 and with sufficient laboratory test results to calculate their Fibrosis-4 (FIB-4) scores. The mean age was 78.35 years, 97.1% were men, and 80.7% were White individuals.
The FIB-4 score for each patient was calculated using the most recent alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels or values and platelet values that were closest to the index date during the two years after the index dementia date.
Age is in the numerator of the FIB-4 score calculation; hence, higher age could lead to an erroneously high FIB-4 score, the authors noted. Therefore, for patients older than 65 years, the researchers entered 65 years as an input variable, rather than the actual age.
A FIB-4 score > 2.67 was suggestive of advanced fibrosis, whereas a score > 3.25 was suggestive of cirrhosis.
A total of 18,390 (10.3%) veterans had a FIB-4 score > 2.67, and 9373 (5.3%) had a FIB-4 score > 3.25.
In multivariable logistic regression models, a FIB-4 score > 3.25 was associated with older age (odds ratio [OR], 1.07), male sex (OR, 1.43), congestive heart failure (OR, 1.48), viral hepatitis (OR, 1.79), an Alcohol Use Disorders Identification Test score showing problem drinking (OR, 1.56), and chronic kidney disease (OR, 1.11).
In contrast, a FIB-4 score > 3.25 was inversely associated with the White race (OR, 0.79), diabetes (OR, 0.78), hyperlipidemia (OR, 0.84), stroke (OR, 0.85), tobacco use disorder (OR, 0.78), and rural residence (OR, 0.92).
Similar findings were associated with the FIB-4 greater than 2.67 threshold.
In a follow-up validation study among 89 veterans diagnosed with dementia at a single center, the researchers found similar results: 4.4%-11.2% of participants had high FIB-4 scores, suggestive of HE.
After investigating further, they concluded that 5% of patients in that cohort had reasons other than cirrhosis for their high FIB-4 scores. The remaining patients (95%) had evidence of cirrhosis, had risk factors, and/or had no other explanation for their high FIB-4 scores.
“The combination of high FIB-4 scores and other risk factors for liver disease in patients with dementia raises the possibility that reversible HE could be a factor associated with cognitive impairment,” the authors wrote. “These findings highlight the potential to enhance cognitive function and quality of life by increasing awareness of risk factors and diagnostic indicators of advanced liver disease that may be associated with HE as a factor or as a differential diagnosis of dementia among clinicians other than liver specialists.”
FIB-4 Screening Advised
“An elderly patient with cirrhosis used to be an oxymoron, because we never used to have people who lived this long or were diagnosed this late with cirrhosis,” Dr. Bajaj told this news organization. “It’s a good problem to have because people are now living longer, but it also means that we need to have every single person who is taking care of patients with what is deemed to be dementia know that the patient could also have an element of encephalopathy.”
Increased awareness is important because, unlike dementia, encephalopathy is very easily treated, Dr. Bajaj said. “The biggest, easiest, correctable cause is to figure out if they have severe liver disease, and if that’s the case, your friendly neighborhood gastroenterologist is waiting for you,” he added.
The finding that cirrhosis was present in 95% of patients in the validation cohort is “very impressive, as they had excluded from the consideration all those with obvious cirrhosis before the FIB-4 was done,” said William Carey, MD, acting hepatology section head in the Department of Gastroenterology, Hepatology and Nutrition at Cleveland Clinic’s Digestive Disease Institute in Ohio. “This validates FIB-4 as a powerful tool for cirrhosis case-finding.”
Ordering a FIB-4 “is within the skill set of every healthcare provider,” Dr. Carey, who was not involved in the study, told this news organization. “Patients with altered mental status, including suspected or proven dementia, should be screened for possible cirrhosis, as future management will change. Those with elevated FIB-4 results should also be tested for possible HE and treated if it is present.”
The study was partly funded by VA Merit Review grants to Dr. Bajaj. Dr. Bajaj reported receiving grants from Bausch, Grifols, Sequana, and Mallinckrodt outside the submitted work. Dr. Carey reported no relevant disclosures.
A version of this article appeared on Medscape.com.
Cognitive impairment in some US veterans may be due to treatable hepatic encephalopathy (HE) rather than dementia, new research suggested.
From 5%-10% of veterans diagnosed with dementia had possible undiagnosed cirrhosis, implicating HE as a contributor to cognitive impairment, found the study by Jasmohan S. Bajaj, MD, of Virginia Commonwealth University and Richmond VA Medical Center, Virginia, and colleagues.
The research was prompted, in part, by an earlier case study by Dr. Bajaj and colleagues that showed that two older men diagnosed with dementia and Parkinson’s disease actually had HE, meaning their symptoms were due to advanced but treatable liver disease.
It’s not that clinicians don’t know how to treat HE; the problem was that they did not suspect it.”
Among veterans with cirrhosis, concomitant dementia is common and is difficult to distinguish from HE, but the extent to which patients with dementia also have undiagnosed cirrhosis and HE is unknown, the authors of the current study wrote. “Undiagnosed cirrhosis among veterans with dementia could raise the possibility that part of their cognitive impairment may be due to reversible HE,” they added.
To investigate, the researchers examined the prevalence and risk factors of undiagnosed cirrhosis — and therefore, possible HE — among US veterans.
The study was published online in JAMA Network Open.
Dementia or Cirrhosis?
Using the VHA Corporate Data Warehouse, researchers analyzed medical records of 177,422 US veterans diagnosed with dementia but not cirrhosis between 2009 and 2019 and with sufficient laboratory test results to calculate their Fibrosis-4 (FIB-4) scores. The mean age was 78.35 years, 97.1% were men, and 80.7% were White individuals.
The FIB-4 score for each patient was calculated using the most recent alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels or values and platelet values that were closest to the index date during the two years after the index dementia date.
Age is in the numerator of the FIB-4 score calculation; hence, higher age could lead to an erroneously high FIB-4 score, the authors noted. Therefore, for patients older than 65 years, the researchers entered 65 years as an input variable, rather than the actual age.
A FIB-4 score > 2.67 was suggestive of advanced fibrosis, whereas a score > 3.25 was suggestive of cirrhosis.
A total of 18,390 (10.3%) veterans had a FIB-4 score > 2.67, and 9373 (5.3%) had a FIB-4 score > 3.25.
In multivariable logistic regression models, a FIB-4 score > 3.25 was associated with older age (odds ratio [OR], 1.07), male sex (OR, 1.43), congestive heart failure (OR, 1.48), viral hepatitis (OR, 1.79), an Alcohol Use Disorders Identification Test score showing problem drinking (OR, 1.56), and chronic kidney disease (OR, 1.11).
In contrast, a FIB-4 score > 3.25 was inversely associated with the White race (OR, 0.79), diabetes (OR, 0.78), hyperlipidemia (OR, 0.84), stroke (OR, 0.85), tobacco use disorder (OR, 0.78), and rural residence (OR, 0.92).
Similar findings were associated with the FIB-4 greater than 2.67 threshold.
In a follow-up validation study among 89 veterans diagnosed with dementia at a single center, the researchers found similar results: 4.4%-11.2% of participants had high FIB-4 scores, suggestive of HE.
After investigating further, they concluded that 5% of patients in that cohort had reasons other than cirrhosis for their high FIB-4 scores. The remaining patients (95%) had evidence of cirrhosis, had risk factors, and/or had no other explanation for their high FIB-4 scores.
“The combination of high FIB-4 scores and other risk factors for liver disease in patients with dementia raises the possibility that reversible HE could be a factor associated with cognitive impairment,” the authors wrote. “These findings highlight the potential to enhance cognitive function and quality of life by increasing awareness of risk factors and diagnostic indicators of advanced liver disease that may be associated with HE as a factor or as a differential diagnosis of dementia among clinicians other than liver specialists.”
FIB-4 Screening Advised
“An elderly patient with cirrhosis used to be an oxymoron, because we never used to have people who lived this long or were diagnosed this late with cirrhosis,” Dr. Bajaj told this news organization. “It’s a good problem to have because people are now living longer, but it also means that we need to have every single person who is taking care of patients with what is deemed to be dementia know that the patient could also have an element of encephalopathy.”
Increased awareness is important because, unlike dementia, encephalopathy is very easily treated, Dr. Bajaj said. “The biggest, easiest, correctable cause is to figure out if they have severe liver disease, and if that’s the case, your friendly neighborhood gastroenterologist is waiting for you,” he added.
The finding that cirrhosis was present in 95% of patients in the validation cohort is “very impressive, as they had excluded from the consideration all those with obvious cirrhosis before the FIB-4 was done,” said William Carey, MD, acting hepatology section head in the Department of Gastroenterology, Hepatology and Nutrition at Cleveland Clinic’s Digestive Disease Institute in Ohio. “This validates FIB-4 as a powerful tool for cirrhosis case-finding.”
Ordering a FIB-4 “is within the skill set of every healthcare provider,” Dr. Carey, who was not involved in the study, told this news organization. “Patients with altered mental status, including suspected or proven dementia, should be screened for possible cirrhosis, as future management will change. Those with elevated FIB-4 results should also be tested for possible HE and treated if it is present.”
The study was partly funded by VA Merit Review grants to Dr. Bajaj. Dr. Bajaj reported receiving grants from Bausch, Grifols, Sequana, and Mallinckrodt outside the submitted work. Dr. Carey reported no relevant disclosures.
A version of this article appeared on Medscape.com.
Cognitive impairment in some US veterans may be due to treatable hepatic encephalopathy (HE) rather than dementia, new research suggested.
From 5%-10% of veterans diagnosed with dementia had possible undiagnosed cirrhosis, implicating HE as a contributor to cognitive impairment, found the study by Jasmohan S. Bajaj, MD, of Virginia Commonwealth University and Richmond VA Medical Center, Virginia, and colleagues.
The research was prompted, in part, by an earlier case study by Dr. Bajaj and colleagues that showed that two older men diagnosed with dementia and Parkinson’s disease actually had HE, meaning their symptoms were due to advanced but treatable liver disease.
It’s not that clinicians don’t know how to treat HE; the problem was that they did not suspect it.”
Among veterans with cirrhosis, concomitant dementia is common and is difficult to distinguish from HE, but the extent to which patients with dementia also have undiagnosed cirrhosis and HE is unknown, the authors of the current study wrote. “Undiagnosed cirrhosis among veterans with dementia could raise the possibility that part of their cognitive impairment may be due to reversible HE,” they added.
To investigate, the researchers examined the prevalence and risk factors of undiagnosed cirrhosis — and therefore, possible HE — among US veterans.
The study was published online in JAMA Network Open.
Dementia or Cirrhosis?
Using the VHA Corporate Data Warehouse, researchers analyzed medical records of 177,422 US veterans diagnosed with dementia but not cirrhosis between 2009 and 2019 and with sufficient laboratory test results to calculate their Fibrosis-4 (FIB-4) scores. The mean age was 78.35 years, 97.1% were men, and 80.7% were White individuals.
The FIB-4 score for each patient was calculated using the most recent alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels or values and platelet values that were closest to the index date during the two years after the index dementia date.
Age is in the numerator of the FIB-4 score calculation; hence, higher age could lead to an erroneously high FIB-4 score, the authors noted. Therefore, for patients older than 65 years, the researchers entered 65 years as an input variable, rather than the actual age.
A FIB-4 score > 2.67 was suggestive of advanced fibrosis, whereas a score > 3.25 was suggestive of cirrhosis.
A total of 18,390 (10.3%) veterans had a FIB-4 score > 2.67, and 9373 (5.3%) had a FIB-4 score > 3.25.
In multivariable logistic regression models, a FIB-4 score > 3.25 was associated with older age (odds ratio [OR], 1.07), male sex (OR, 1.43), congestive heart failure (OR, 1.48), viral hepatitis (OR, 1.79), an Alcohol Use Disorders Identification Test score showing problem drinking (OR, 1.56), and chronic kidney disease (OR, 1.11).
In contrast, a FIB-4 score > 3.25 was inversely associated with the White race (OR, 0.79), diabetes (OR, 0.78), hyperlipidemia (OR, 0.84), stroke (OR, 0.85), tobacco use disorder (OR, 0.78), and rural residence (OR, 0.92).
Similar findings were associated with the FIB-4 greater than 2.67 threshold.
In a follow-up validation study among 89 veterans diagnosed with dementia at a single center, the researchers found similar results: 4.4%-11.2% of participants had high FIB-4 scores, suggestive of HE.
After investigating further, they concluded that 5% of patients in that cohort had reasons other than cirrhosis for their high FIB-4 scores. The remaining patients (95%) had evidence of cirrhosis, had risk factors, and/or had no other explanation for their high FIB-4 scores.
“The combination of high FIB-4 scores and other risk factors for liver disease in patients with dementia raises the possibility that reversible HE could be a factor associated with cognitive impairment,” the authors wrote. “These findings highlight the potential to enhance cognitive function and quality of life by increasing awareness of risk factors and diagnostic indicators of advanced liver disease that may be associated with HE as a factor or as a differential diagnosis of dementia among clinicians other than liver specialists.”
FIB-4 Screening Advised
“An elderly patient with cirrhosis used to be an oxymoron, because we never used to have people who lived this long or were diagnosed this late with cirrhosis,” Dr. Bajaj told this news organization. “It’s a good problem to have because people are now living longer, but it also means that we need to have every single person who is taking care of patients with what is deemed to be dementia know that the patient could also have an element of encephalopathy.”
Increased awareness is important because, unlike dementia, encephalopathy is very easily treated, Dr. Bajaj said. “The biggest, easiest, correctable cause is to figure out if they have severe liver disease, and if that’s the case, your friendly neighborhood gastroenterologist is waiting for you,” he added.
The finding that cirrhosis was present in 95% of patients in the validation cohort is “very impressive, as they had excluded from the consideration all those with obvious cirrhosis before the FIB-4 was done,” said William Carey, MD, acting hepatology section head in the Department of Gastroenterology, Hepatology and Nutrition at Cleveland Clinic’s Digestive Disease Institute in Ohio. “This validates FIB-4 as a powerful tool for cirrhosis case-finding.”
Ordering a FIB-4 “is within the skill set of every healthcare provider,” Dr. Carey, who was not involved in the study, told this news organization. “Patients with altered mental status, including suspected or proven dementia, should be screened for possible cirrhosis, as future management will change. Those with elevated FIB-4 results should also be tested for possible HE and treated if it is present.”
The study was partly funded by VA Merit Review grants to Dr. Bajaj. Dr. Bajaj reported receiving grants from Bausch, Grifols, Sequana, and Mallinckrodt outside the submitted work. Dr. Carey reported no relevant disclosures.
A version of this article appeared on Medscape.com.
FROM JAMA NETWORK OPEN